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Form 483 issued to Alexion’s Rhode Island Site by USFDA

The US Food and Drug Administration (FDA) recently completed a routine current Good Manufacturing Practice (GMP) inspection of Alexion’s Smithfield, Rhode Island manufacturing facility and issued a Form 483 with three observations.

According to the company, observations are inspectional, and do not represent a final FDA determination of compliance. The observations pertain to: completion and closure of certain investigations, validation of surface sampling methods, and monitoring of water systems.

FDA already issued a warning letter to the same manufacturing site which produces the immunosuppressant Soliris (eculizumab), among other products.

The three observations are as detailed below: • Alexion did not conduct an adequate assessment of the impact of this contamination on your final product, including the potential for non-host cell particle contamination. Alexion did not evaluate the ability of your manufacturing process to clear non-host cell impurities.
• While Alexion had moved to introduce cleaning agents to decontaminate its clean room, the company never verified its effectiveness before resuming production of its Soliris API.
• In another instance, two API lots of Soliris were found to have not met pre-specified limits for quality and safety, but were released by staff without "adequate scientific justification.


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